Methods of forming prostheses

ABSTRACT

A breast prosthesis may be formed by forming an outer layer on a mold, and filling the mold with a polymerizable foaming composition. The mold may be formed by forming a computer model of the prosthesis based on scanning a patient. The computer model may be used to form a solid model. A prosthesis may be coupled to the patient by coupling at least one metallic insert to the prosthesis and at least one magnet to the patient. Alternately, the prosthesis may be formed with a retaining harness integral to the prosthesis. In still another method, the prosthesis may be coupled to a retaining device surgically implanted in the patient.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention relates to prosthetic devices, methods andsystems for forming prosthetic devices, and methods and systems forcoupling a prosthetic device to a patient.

[0003] 2. Description of the Relevant Art

[0004] A prosthesis may be used by a patient desiring to augment damagedor deficient anatomy. For example, after a mastectomy, a patient maychoose to augment anatomy damaged by the surgery. At its simplest, abreast prosthesis may take the form of external material to be added tothe patient's bra. The prosthesis may provide both form and weight toaugment the patient's anatomy. A breast prosthesis may be surgicallyimplantable (requiring a surgeon's skill).

[0005] Between these two extremes, a custom external breast prosthesismay be formed. The custom prosthesis may be designed to replicate thepatient's damaged anatomy. Custom prostheses have been formed bytechniques requiring multiple casting steps. In particular, specialcasting steps may be required to create a custom prosthesis that mirrorsa portion of the patient's anatomy. Other methods may require a skilledsculptor to replicate a portion of the patient's anatomy. Additionally,breast prostheses have been formed of various materials. A prosthesismay be formed of materials that allow comfortable use of the prosthesisover an extended period of time. Silicone polymers have been used toproduce such prostheses.

[0006] Methods of coupling a prosthesis to a patient may includeadhesives. For example, one method is to attach the prosthesis directlyto the chest of the patient with adhesives. This method may be anuncomfortable solution and may not always be effective. Furthermore, atight adhesive fit to the chest may trap heat and prevent ventilation ofthe skin surface. Another common method is to place the prosthesis in apocket of a bra. This method may also present concerns since theprosthesis may shift out of position within the bra.

SUMMARY OF THE INVENTION

[0007] In an embodiment, a model of a breast prosthesis may be formed byproviding a scanning system. The scanning system may include at leastone imaging device, and at least one alignment marker. At least onealignment marker may be arranged with respect to a patient and withinthe field of view of the imaging device. A first set of data elementsmay be determined using the scanning system. The first set of dataelements may be based on the patient's breast while the patient's breastis at least partially covered by a garment (e.g., a bra or a swimsuit).A computer model of a breast prosthesis may be determined based on thefirst set of data elements. At least one alignment marker may be used todetermine alignment of the computer model.

[0008] In an embodiment, a computer program may receive the first set ofdata elements determined by scanning the patient. The first set of dataelements may correspond to a first surface. A second set of dataelements may be determined based on the first set of data elements. Thesecond set of data elements may correspond to a second surface. Thesecond surface may be a mirror image of the first surface. The computerprogram may be further configured to receive a third set of dataelements determined by scanning the patient over an area including atleast the patient's surgical site. The third set of data elements maycorrespond to a third surface. The third surface may represent thepatient's chest in an area including the surgical site. A computerizedmodel of a breast prosthesis may be determined based on the second setof data elements, the third set of data elements and/or a combination ofthe two. The computer program may send a signal to a rapid prototypingsystem based on the computerized model of the breast prosthesis. Thesignal may provide instructions to the rapid prototyping system forgenerating a model of the breast prosthesis. The model of the breastprosthesis may be used to form a mold for casting a breast prosthesis.

[0009] In an embodiment, a breast prosthesis may be formed by forming anouter layer on at least a portion of the interior of a mold. The outerlayer may be formed by applying at least one layer of a polymerizablecomposition to at least a portion of the interior of the mold. Afterforming the outer layer, at least a portion of the mold may be filledwith a polymerizable foaming composition. The mold may be assembled toinhibit the polymerizable foaming composition from expanding beyond themold. The polymerizable foaming composition may be cured. Thepolymerizable foaming composition may be removed from the mold. Theouter layer may be coupled to the cured foaming composition. Theposterior portion may have a shape configured to conform to a portion ofa chest wall of a patient.

[0010] In an embodiment, the posterior portion may include a texturedsurface. The textured surface may be formed by applying a polymer layerto a mold having a textured surface. The mold having the texturedsurface may be formed by applying a polymerizable solvent composition toa substrate. The polymerizable solvent composition may at leastpartially dissolve the surface of the substrate as it cures, providing atextured surface to the polymerizable solvent composition. The curedpolymerizable solvent composition may be used to form a textured mold.

[0011] In an embodiment, a prosthesis may be coupled to a patient bycoupling at least one metallic insert to the prosthesis. At least onemagnet may be adhered to the patient. At least one magnet adhered to thepatient may be aligned with at least one metallic insert of theprosthesis. For example, at least one magnet may be placed in anadhesive backed pouch. The prosthesis may be coupled to the patient suchthat at least one magnet and at least one metallic insert are alignedsufficiently to retain the prosthesis in position relative to thepatient.

[0012] In another embodiment, a prosthesis may be coupled to a patientby a retaining harness integral with the prosthesis. The retainingharness may extend around the neck of the patient. The retaining harnessmay be formed of the same material as the outer layer of the prosthesis.The harness may further include an opening through which an intactbreast may project.

[0013] In an embodiment, a breast prosthesis may include a plurality ofchambers. At least one chamber may include a gel. At least one chambermay include a foam material. At least one layer of a polymer mayseparate at least two chambers. Additionally, at least one chamber mayinclude air.

[0014] In still another embodiment, a prosthesis may be retained by asurgically implanted retaining device. The surgically implantedretaining device may include a flange, a percutaneous abutment, afixation connector, a fixture mount, and a retaining connector.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Other objects and advantages of the invention will becomeapparent upon reading the following detailed description and uponreference to the accompanying drawings in which:

[0016]FIG. 1 depicts an embodiment of a computer system;

[0017]FIG. 2 depicts an embodiment of a system for forming a model of abreast prosthesis;

[0018]FIG. 3 depicts a flowchart of an embodiment of a method of forminga model of a breast prosthesis;

[0019]FIG. 4 depicts a flowchart of an embodiment of a method of forminga breast prosthesis;

[0020]FIG. 5 depicts an embodiment of a breast prosthesis mold;

[0021]FIG. 6 depicts an embodiment of a breast prosthesis mold in amolding box;

[0022]FIG. 7 depicts a flowchart of a method of forming a mold forcasting a textured backing;

[0023]FIG. 8 depicts an embodiment of a breast prosthesis havingmultiple chambers;

[0024]FIG. 9a depicts a side cutaway view of an embodiment of a breastprosthesis retained by a plurality of coupling devices;

[0025]FIG. 9b depicts a front view of an embodiment of a breastprosthesis retained by a plurality of adhesively attached couplingdevices;

[0026]FIG. 10 depicts an exploded view of a pouch for coupling a magnetto a patient;

[0027]FIGS. 11a and 11 b depict front and side views, respectively, ofan embodiment of a prosthesis having an integral retaining device;

[0028]FIG. 12a depicts an exploded view of an embodiment of anosseointegrated prosthesis retaining device; and

[0029]FIG. 12b depicts an assemble view of an embodiment of anosseointegrated prosthesis retaining device.

[0030] While the invention is susceptible to various modifications andalternative forms, specific embodiments thereof are shown by way ofexample in the drawings and will herein be described in detail. Itshould be understood, however, that the drawing and detailed descriptionthereto are not intended to limit the invention to the particular formdisclosed, but on the contrary, the intention is to cover allmodifications, equivalents and alternatives falling within the spiritand scope of the present invention as defined by the appended claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] Embodiments disclosed herein generally relate to prostheses, andmethods and systems of forming prostheses. The embodiments are generallydescribed in terms of breast prostheses; however, it is recognized thatmethods and systems described herein may be used to form a variety ofprostheses, and are not limited to breast prostheses.

[0032] Prostheses and methods of forming prostheses are disclosed inU.S. Pat. No. 5,376,323 to Eaton, U.S. Pat. No. 5,700,288 to Eaton, U.S.Pat. No. 5,798,062 to Thielbar, U.S. Pat. No. 5,855,606 to Eaton, U.S.Pat. No. 6,074,420 to Eaton, U.S. Pat. No. 6,086,801 to Eaton, U.S. Pat.No. 6,136,027 to Jackson, U.S. Pat. No. 6,156,065 to Eaton, U.S. Pat.No. 6,315,796 to Eaton and in pending U.S. patent application Ser. No.09/484,155 filed Jan. 18, 2000 each of which is incorporated herein byreference as though fully set forth herein. Methods of forming computermodels of three dimensional objects are disclosed in U.S. Pat. No.5,455,590 to Collins et al, U.S. Pat. No. 5,513,276 to Theodoracatos,U.S. Pat. No. 5,557,283 to Sheen et al., U.S. Pat. No. 5,859,609 toSheen et al., and U.S. Pat. No. 5,870,220 to Migdal et al. each of whichis incorporated herein by reference as though fully set forth herein.Methods of forming solid models using computer-controlled devices aredisclosed in U.S. Pat. No. 4,915,757 to Rando, U.S. Pat. No. 5,140,937to Yamane et al., U.S. Pat. No. 5,776,409 to Almquist et al., each ofwhich is incorporated herein by reference as though fully set forthherein.

[0033]FIG. 1 illustrates an embodiment of computer system 150 that maybe suitable for implementing various embodiments disclosed herein. Eachcomputer system 150 typically includes components such as centralprocessing unit (CPU) 152 with an associated memory medium such asfloppy disks 160. The memory medium may store program instructions forcomputer programs. The program instructions may be executable by CPU152. Computer system 150 may further include a display device such asmonitor 154, an alphanumeric input device such as keyboard 156, and adirectional input device such as mouse 158. Computer system 150 may beoperable to execute one or more computer programs to acquire an image ofan anatomical feature of a patient, to manipulate an image of ananatomical feature of a patient and/or to control a rapid prototypingsystem.

[0034] Computer system 150 may include a memory medium on which computerprograms according to various embodiments may be stored. The term“memory medium” is intended to include an installation medium (e.g., aCD-ROM or floppy disks 160), a computer system memory (e.g., DRAM, SRAM,EDO RAM, Rambus RAM, etc.), or a non-volatile memory (e.g., magneticmedia, or optical media). The memory medium may also include other typesof memory or combinations thereof. In addition, the memory medium may belocated in a first computer which executes the programs or may belocated in a second different computer which connects to the firstcomputer over a network. In the latter instance, the second computer mayprovide the program instructions to the first computer for execution.Computer system 150 may take various forms such as a personal computersystem, mainframe computer system, workstation, network appliance,Internet appliance, personal digital assistant (“PDA”), televisionsystem or other device. In general, the term “computer system” may referto any device having a processor that executes instructions from amemory medium.

[0035] The memory medium may store a software program or programsoperable to implement embodiments disclosed herein. The softwareprogram(s) may be implemented in various ways, including, but notlimited to, procedure-based techniques, component-based techniques,and/or object-oriented techniques, among others. For example, thesoftware programs may be implemented using ActiveX controls, C++objects, JavaBeans, Microsoft Foundation Classes (“MFC”), browser-basedapplications (e.g., Java applets), traditional programs, or othertechnologies or methodologies, as desired. A CPU such as host CPU 152executing code and data from the memory medium may include a means forcreating and executing the software program or programs according to theembodiments described herein.

[0036]FIG. 2 illustrates a network 200 according to one embodiment. Inan embodiment, network 200 may include a wide area network (WAN) or alocal area network (LAN). A WAN refers to a network that spans arelatively large geographical area. The Internet is an example of a WAN.A WAN typically includes a plurality of computer systems that may beinterconnected through one or more networks. Although one particularconfiguration is shown in FIG. 2, a WAN may include a variety ofheterogeneous computer systems and networks that may be interconnectedin a variety of ways and that may run a variety of softwareapplications.

[0037] A LAN refers to a network that spans a relatively small area.Typically, a LAN may be confined to a single building or group ofbuildings. One or more LANs may be coupled to WAN. Each node (i.e.,individual computer system or device) of a network may have its own CPUwith which it may execute programs, and each node may also be able toaccess data and devices elsewhere on the network. A network may becharacterized by a variety of types of topology (i.e., the geometricarrangement of devices on the network), of protocols (i.e., the rulesand encoding specifications for sending data, and whether the networkuses a peer-to-peer or client/server architecture), and of media (e.g.,twisted-pair wire, coaxial cables, fiber optic cables, and/or radiowaves).

[0038] As illustrated in FIG. 2, two or more devices configured to carryout methods described herein may communicate via a network 200. Forexample, a scanning system 202 may gather information regarding apatient 204. Scanning system 202 may include an imaging device. In anembodiment, scanning system 202 may also include a computer system. Inan alternate embodiment, an imaging device of scanning system 202 mayprovide image information to computer system 206 without an intermediatecomputer system. Scanning system 202 may provide at least some of thegathered information to a computer system 206. In various embodiments,information may be provided to computer system 206 via a removablememory medium (e.g., a CD-ROM) or via network 200. Computer system 206may include one or more software applications executable to manipulategraphical information. For example, a software application available oncomputer system 206 may provide a graphical display of a computer modelbased on the information provided by scanning system 202. In addition, asoftware application available on computer system 206 may be executableto manipulate a computer model. In an embodiment, the softwareapplication may be executable to manipulate data elements of thecomputer model. For example, the software application may determine ifone or more data elements are missing (e.g., from data corruption orimperfections in the scanning process). If one or more data elements aredetermined to be missing, the software application may approximate theposition of the missing data elements (e.g., to provide a continuoussurface on the computer model). In another example of manipulating thedata elements of the computer model, the software application may beexecutable to remove certain data elements. For example, since ascanning process may be conducted while the patient's breast is at leastpartially covered by a garment (e.g., a bra or swimsuit), the softwareapplication may be executable to remove data elements associated withthe garment. In such a case, the removed data elements may be replacedwith data elements approximating the surface of the breast. In addition,computer system 206 may include at least one software applicationexecutable to determine a mirror image of a computer model. Computersystem 206 may also include at least one software application executableto combine two or more computer models into a single computer model.

[0039] Computer system 206 may provide information regarding a computermodel to a rapid prototyping system 208. In various embodiments,information regarding the computer model may be provided to computersystem 206 via a removable memory medium (e.g., a CD-ROM) or via network200. Rapid prototyping system 208 may include at least one manufacturingdevice for forming a solid model substantially corresponding to thecomputer model. Rapid prototyping system 208 may include a computersystem configured to convert information regarding the computer modelinto a control signal to be sent to at least one solid model formingdevice. Alternately, computer system 206 may send the informationregarding the computer model to rapid prototyping system 208 in the formof a control signal.

[0040] Various embodiments may also include receiving or storinginstructions and/or data implemented in accordance with the foregoingdescription upon a carrier medium. Suitable carrier media may includestorage media or memory media such as magnetic or optical media, (e.g.,a hard-disk or CD-ROM). Suitable carrier media may also include signalssuch as electrical, electromagnetic, optical signals (whether digital oranalog). Such signals may be conveyed via a communication medium such asnetwork 200 and/or a wireless link.

[0041] In an embodiment, the arrangement depicted in FIG. 2 may allowpatient's to be seen in a different facility than computer modelproduction and/or solid model production. For example, patients may beseen at remote locations while computer and/or solid models are producedat a central manufacturing location. In such an example, scanning system202 may be portable. Thus, scanning system 202 may be relocated tovarious remote locations as desired to conveniently provide services topatients. In an embodiment, both scanning system 202 and computer system206 may be portable. Such an embodiment may allow patients to be scannedat remote locations. After scanning, a patient may be allowed to view acomputer model of a prosthesis. Such embodiments may allow a patient tomake more informed decisions regarding the prosthesis to be formed.

[0042] In an embodiment, a method forming a prosthesis may begin bygathering background information regarding a patient expected to utilizethe prosthesis. For example background information gathered may include,but is not limited to: marketing-related information, medical historyinformation, descriptive information regarding the patient, informationregarding the desired prosthesis, etc. The background information may behelpful to prepare a custom prosthesis for the patient or to select anappropriate non-custom prosthesis. The medical history information mayinclude, but is not limited to: location of mastectomy (e.g., right,left or bilateral), date of mastectomy, location of sensitive areasassociated with the mastectomy (e.g., sensitive scar tissues),sensitivities to various materials (e.g., adhesives), etc. Informationgathered regarding the desired prosthesis may include, but is notlimited to: desired characteristics of the prosthesis (e.g., lightweight, realistic feel, etc.), size, nipple design and color, prosthesiscolor, etc. Descriptive information gathered about the patient mayinclude, but is not limited to: skin complexion information (e.g., skintone, presence of freckles, etc.), bra size and style, etc.

[0043] In an embodiment, additional descriptive information regardingthe patient may be gathered using one or more imaging devices ofscanning system 202. The descriptive information gathered by scanningsystem 202 may be used to generate a computer model of portions of thepatient's anatomy. FIG. 2 depicts an embodiment of a scanning system 202in relation to a patient 204. An imaging device of scanning system 202may include any of a plurality of different devices for gatheringgeometric data to describe a surface or three-dimensional object.Examples of suitable devices may include, but are not limited to: sonicor ultrasonic imaging devices, laser scanning devices andelectromagnetic (EM) wave imaging devices (e.g., a millimeter wavescanner). As used herein, a “millimeter wave” refers to electromagneticradiation having a frequency between about 1 gigahertz and about 300gigahertz. Suitable imaging devices are commercially available fromMinolta Corporation USA of Ramsey, N.J. and Tracer Corporation of BocaRaton, Fla. In an embodiment where a patient has at least one intactbreast, scanning system 202 may be used to gather geometric dataregarding the intact breast. For example, if a patient has anopportunity to prepare a prosthesis before a mastectomy, the patient mayhave both breasts intact. In such a case, both of the patient's breastsmay be scanned. In a more typical example, a patient may seek aprosthesis after having a mastectomy. In such a case, if the patient hasan intact breast, the intact breast may be scanned. As used herein,“scanning” refers to the process of gather geometric data regarding aportion of the patient's anatomy. Scanning results in the creation of aset of data elements representing the scanned surface. For example, thedata elements may represent the surface of the patient's breast and/orthe surface of a garment covering the patient's breast. The set of dataelements from the scan may be used in embodiments disclosed herein toform a breast prosthesis.

[0044] In an embodiment, scanning the patient's anatomy may includehaving the patient at least partially disrobe. Since a breast prosthesisis typically worn with a bra, it may be desirable for the prosthesis tohave a shape corresponding to the shape of the patient's breast whilesupported by a properly fitting bra of the style preferred by thepatient. Thus, scanning may be performed while the patient is wearing aproperly fitted bra or similar garment (e.g., a swimsuit). Alternately,in an embodiment, a patient may desire a prosthesis that can be wornwithout a bra. In such a case, a scan of the patient's bare breast maybe performed. A number of alignment markers 210 may be put on thepatient to allow a computer model to be generated from the scan thatincludes proper alignment information. For example, alignment markersmay be placed on the patient directly below the supra sternal notch,directly below the xiphoid process and on each bilateral clavicularhead. These anatomical features are convenient alignment points;however, it is recognized that other alignment points could be used. Asused herein, an “alignment marker” refers to an object that isnoticeable in a scanned image and may be used in manipulating thescanned image as a reference point. For example, alignment markers mayinclude any object that reflects the scanning medium in a significantlydifferent manner than the patient's skin and/or a garment worn by thepatient. Examples of suitable alignment markers include, but are notlimited to: adhesive-backed members of a variety of shapes and sizes.For example, commercially available, self-adhesive paper or foam dotshave been found to be useful as alignment markers. The patient may bepositioned in the field of view of at least one imaging device ofscanning system 202. Additionally, an orientation marker 212 may bepositioned in the field of view of the imaging device. As used herein,an “orientation marker” refers to a device used to assist a scanneroperator in orienting the scanning system with regard to the patient.Alternatively, an orientation marker may be a device used to assist inorienting the patient with respect to a fixed scanning system. Forexample, an orientation marker may assist the operator in orienting theimaging device and/or patient approximately normal to an imaginary frontsurface plane of the patient. That is, the orientation marker may beused to determine whether the imaging device is at an angle with respectto the patient. The patient may stand between the orientation marker anda wall. The patient's posture may be checked to ensure that the patientis roughly parallel to the wall. For example, the patient's elbows,shoulders and/or buttocks may be positioned so that they touch the wall.The orientation marker may be placed in front of the patient.Measurements may be taken to ensure that the orientation marker issubstantially level and parallel to the wall. Thus, if the orientationmarker is skewed in the scanned image, it may be assumed that theimaging device was not properly oriented with respect to the patient andundesired perspective may have been introduced into the scanned image.The image scanning may be repeated. Alternately, the scanned image ofthe orientation marker may be used by a graphics manipulation softwareapplication as described below to remove the undesired perspective.

[0045] After a mastectomy, the patent's chest may be scanned in an areathat includes the surgical site. It may be desirable to postponescanning the patient's surgical site until sufficient time has elapsedsince the surgery for swelling to substantially subside. Scanning thesurgical site may form a set of data elements corresponding to thesurface of the patient's chest in the area where the prosthesis will beworn. In addition to the scans of the patient's anatomy, one or morephotographs of the patient may be taken. Once the backgroundinformation, including scans, has been collected, it may be saved andfiled for use during modeling and production of the prosthesis.

[0046] Data elements from scanning the patient's anatomy may be providedto computer system 206 for formation of an electronic model of thedesired breast prosthesis. FIG. 3 depicts a flowchart of an exemplaryembodiment of a method of forming a model of a breast prosthesis. Inboxes 302 and 304, the breast scan data and surgical site scan data maybe prepared. To prepare the scan data, the data may be provided to agraphical imaging software application. For example, a commerciallyavailable computer aided design or computer aided modeling (CAD/CAM)software application with three-dimensional modeling capabilities may beused. Software applications are available from TracerCAD, and RaindropGeomagic of Research Triangle Park, NC. The graphical imaging softwareapplication may be used to form a computer model of the scanned areas.As used herein, a “model” refers to a physical or graphicalrepresentation of an object. The scan data may be filtered to identifyportions of the data that are missing and/or corrupted. Known techniquesmay be used to interpolate or otherwise adjust for missing and/orcorrupted data. Preparing the scan data may also include identifying thealignment markers in the computer models. At box 306, a reflectiontransformation may be applied to the breast computer model to form amirror image of the breast computer model. Thus, if the patient's rightbreast was scanned, the reflection transformation may create a leftbreast that is an exact duplicate of the right breast but oriented forthe patient's left side. The perimeter of the breast computer model maybe identified at box 308. Identifying the perimeter of the breastcomputer model may establish the edge of the form and allow a depthmeasurement to be made to ensure symmetry. The breast model and surgicalsite model may be combined at box 310. In the combined model, the breastmodel may form the anterior surface while the surgical site model formsthe posterior surface. Thus, a complete electronic model of a breastprosthesis is formed wherein the front of the breast prosthesis mirrorsthe shape of the patient's intact breast and the back of the prosthesisis custom fit to the patient's surgical site. In an embodiment, thecomputer model of the breast prosthesis may be manipulated to formdesired features and/or removed undesired features. For example, since apatient's breast may be scanned while the breast is at least partiallycovered by a garment, the computer model may be adjusted to have a shapeapproximating the shape of the patient's breast inside the garment. Forexample, seam lines may be removed and/or physical characteristics notclear through the garment (e.g., the nipple region) may be added. Inanother example, the back of the prosthesis computer model may beadjusted to provide additional clearance over sensitive areas to ensurethat the actual prosthesis will not contact these areas. In yet anotherexample the back of the prosthesis computer model may be provided with atextured surface.

[0047] In the case of a patient who had a breast scanned before amastectomy was performed, the reflection transformation may be omitted.Thus, the front of a formed prosthesis may match the removed breast,while the back of the prosthesis may be matched to the patient'ssurgical area. In the case of a patient with no intact breast to scan(e.g., after a bilateral mastectomy), several different methods may beused to provide suitable prostheses. In a first embodiment, two breastprosthesis models may be selected from a database computer models. Forexample, at least some of the breast computer models formed by methodsdescribed above may be stored in a computer memory. In such a case,these breast computer models may be available for review by patients toselect one or more desired breast computer models. The selected breastcomputer model or models may be combined with scans of the patient'ssurgical sites to form two custom prosthesis computer models. In asecond embodiment, the patient may be scanned while wearing a bra. Atleast one cup of the bra may be filled with any suitable material toform the cup into a desired shape. The filled bra cup may be scanned. Acomputer model of the scanned bra cup may be used along with scans ofthe patient's surgical areas to form two prosthesis computer models. Insuch a case, the reflection transformation step may be used in formingonly one of the prosthesis computer models.

[0048] A computer model of a breast prosthesis may be used to controlrapid prototyping system 208. As used herein, “rapid prototyping” mayrefer to computer controlled formation of a solid model. Examples ofrapid prototyping systems may include, but are not limited to: computernumerical controlled (CNC) milling systems, stereo lithography systems,laser sintering systems, etc. Rapid prototyping systems are commerciallyavailable from a variety of manufacturers. Such systems may include amanufacturing device for forming a solid model and one or more computersystems for controlling the manufacturing device. A set of data elementscorresponding to a computerized model may be provided to rapidprototyping system 208, resulting in the formation of a solid model of abreast prosthesis. For example, a CNC milling machine may be used toform a breast prosthesis model out of a polyurethane blank.

[0049] A breast prosthesis model formed by a rapid prototyping systemmay require hand finishing. For example, some rapid prototyping methodsmay form slightly uneven surfaces, which may be sanded to create smoothsurfaces. Once a satisfactory solid model has been formed, the model maybe used to form a mold for the breast prosthesis. The solid model may bedivided into a breast portion and a surgical site portion. The nippleregion of the breast model may be marked. A mold release agent may beapplied to the breast model and to the surgical site model. The breastmodel may be placed in a mold forming box. The mold forming box may havean adjustable size to accommodate prosthesis models of varying sizes.

[0050] A mold forming composition (e.g., plaster) may be used to form amold around the prosthesis model. For example, a mixture of water andwhite orthodontic stone has been found to be a suitable mold formingcomposition. The orthodontic stone may be acquired as a powder, whichmay be mixed (e.g., with an handheld electric mixer) with water to asuitable consistency. For example, a mixture in the ratio of about 28 mlwater per 100 grams of orthodontic stone has been found to create asuitable consistency. After mixing, the mold forming composition may beallowed to sit for a period of time to allow some air to escape and toallow catalysis of the composition to begin. The mold formingcomposition may be poured into the mold forming box such that the entirebreast model is covered. The surgical site model may be coated with themold forming composition to form the back mold. The mold formingcomposition may be allowed to harden. When the mold forming compositionis substantially hardened, the breast model and surgical site model maybe removed from the mold forming composition, leaving behind the desiredmolds. The molds may be hand sanded, and imperfections in the surface ofthe molds may be filled so that a smooth surface is formed. The moldsmay be allowed to continue to cure for a period of time (e.g., about 5days).

[0051] When the molds are ready, the prosthesis casting process maybegin. A flowchart of an embodiment of a breast prosthesis castingprocess is depicted in FIG. 4. In addition, FIGS. 5 and 6 depict cutaway views of a breast prosthesis mold during the forming process.

[0052] An outer layer 502 may be formed on at least a portion of theinterior of the mold. Outer layer 502 may be formed of one or morepolymer layers. A layer of a polymer may be formed on the interior ofmold 500 by applying a polymerizable composition to mold 500 (see box402 of FIG. 4), and curing the polymerizable composition (see box 404 ofFIG. 4). In various embodiments, the polymerizable composition may besprayed and/or brushed onto the mold. The polymerizable composition mayinclude any of a number of commercially available polymers that may formsoft, non-irritating layers. For example, silicone polymers are usefulin this regard. For example, LIM 6010 silicone, commercially availablefrom GE Silicones of Waterford, N.Y. may be used. LIM 6010 is a two-partcomposition including LIM 6010A and LIM 6010B. Approximately equal partsLIM 6010A and LIM 6010B may be mixed together. A portion of toluene oranother suitable solvent may be added to the mixture as a thinningagent. For example if the polymerizable composition is to be spraycoated over the interior of the mold about 95 grams of toluene may beadded per 100 grams of LIM 6010.

[0053] In an embodiment, the layer of polymer may then be colored byapplying a coloring agent. For example, a silicone dispersion having thedesired color may be used as a coloring agent. A coloring agent mixedinto a polymerizable composition may be brushed or sprayed over at leasta portion of the interior of the polymer layer. The region of thepolymer layer corresponding to the nipple 506 may be colored differentlythan the balance of the polymer layer to provide a more realisticappearance. The nipple color and breast color may be selected and/ormixed to approximate the patient's skin tone and complexion based onphotographs and/or other background information. Applying a layer of apolymerizable composition and curing the layer may be repeated until adesired thickness of the outer layer is established (e.g., about 5layers). As used herein, the “outer layer” refers to one or more polymerlayers that form the exterior (or “skin”) of the prosthesis. In analternate embodiment, only the first polymer layer of the outer layermay be applied then colored. Remaining layers of the outer layer may beapplied with a coloring agent mixed into the polymerizable compositionbefore application. For example, in a mixture of the ratio of about 100grams of LIM 6010 to about 95 grams of toluene, about 12 grams ofcoloring agent may be added for the remaining layers of the outer layer.

[0054] The back mold 600 and front mold 500 may be assembled in amolding box 602 to cast a foam core 606 (see box 408 of FIG. 4). Moldingbox 602 may align the molds and retain them in position during castingof the breast prosthesis. Molding box 602 may include adjustable clamps604 to retain the molds in position. A foaming polymerizable compositionmay be placed in the mold assembly. For example, a foaming polyurethanecomposition may be used. A suitable foaming polymerizable compositionmay include, a mixture in the ratio of about 25 grams of 25880Relastoflex and about 9.5 grams of Isocyanate 25840T, both commerciallyavailable from BASF Corporation of Mount Olive, N.J. may be used. Themixture may be prepared by mixing the two components quickly andthoroughly with a high-speed electric mixer. The mixture may then bepoured into front mold 500. Back mold 600 may be positioned relative tofront mold 500 and molding box 602 may be closed and clamped shut.Molding box 602 may restrain the expansion of the foam. The foamingpolymerizable composition may be allowed to cure (e.g., for about 5minutes).

[0055] After curing, foam core 606 may be removed from molding box 602.The foam may be hand trimmed and shaped (e.g., sanded) as needed to formthe core of the breast prosthesis. In an embodiment, a coloring agentmay be applied to the foam core. The coloring agent may, for example, besprayed or brushed onto the foam core. In such an embodiment, a numberof layers of the coloring agent may be applied to the foam coredepending on the particular coloring agent used, and the desired finalcolor of the core. In multilayer coloring processes, the coloring agentmay be allowed to cure between layers. In an embodiment, one or moreadditional polymer layers may be brushed or sprayed on at least aportion of the interior of the mold after the foam core is removed fromthe mold (see box 409 of FIG. 4). Additional polymer layers may be addeduntil a desired thickness of the outer layer is reached (e.g., about 9additional layers).

[0056] In an embodiment, the foam core may be coupled to outer layer 502of the prosthesis (see box 410 of FIG. 4). An additional layer of apolymer may be used to adhesively couple the foam core to the outerlayer. The additional polymer layer may include a coloring agent. Forexample, Dow Corning 732 silicones (commercially available from DowCorning Corporations of Midland, Mich.) may be mixed with a coloringagent and applied either to the foam core or to the outer layer. Thefoam core may then be inserted into the outer layer. Pressure may beapplied to ensure that the outer layer adheres evenly to the foam core.For example, molding box 602 may be reassembled and clamped togetherwhile the additional polymer layer cures. Alternately, the outer layermay be removed from the mold and carefully placed over to the foam core.Even pressure may be applied to the outer layer by hand to providesubstantially even adhesion to the core.

[0057] In an embodiment, the back of the foam core may be covered withanother layer of a polymerizable composition. In an embodiment, the samecomposition as used for the outer layer may be used to cover the back ofthe foam core. For example, a layer of the polymerizable composition maybe brushed or sprayed over the back surface of the foam core. In anembodiment, the mold clamping box may again be closed and clamped whilethe polymerizable composition cures.

[0058] The breast prosthesis may be removed from the mold by carefullyloosening the outer layer from the mold. In an embodiment, a texturedbacking may be adhered to the prosthesis as described below. Theprosthesis may be trimmed and the edges may be beveled and smoothed.Additionally, any imperfections may be filled using the polymerizablecomposition used to form the outer layer.

[0059] In an embodiment, a textured back surface may be added to abreast prosthesis (see box 414 of FIG. 4). As used herein, a “texturedsurface” refers to a surface that is not smooth. For example, a texturedsurface may be rough. In another example, a textured surface may includetopography configured to reduce the contact area between the patient andthe prosthesis (e.g., to improve ventilation) and/or to provide tactilefeedback to the patient regarding the position of the prosthesis. Atextured surface may include, but is not limited to: a surface having apredetermined, arbitrary or random pattern. For example, a pattern maybe created on the surgical site mold by altering the surgical site moldor by altering the computer model of the surgical site. In anembodiment, a random pattern may be formed on the textured back surfaceby casting the textured back surface using a textured mold (see box 412of FIG. 4). In an embodiment, textured mold may be formed by a methoddescribed with reference to FIG. 7.

[0060]FIG. 7 depicts a flow chart of a method of forming a moldincluding a textured surface. A substrate may be provided at box 702.The substrate may be formed of a material that is at least partiallysoluble in a polymerizable solvent composition. For example, thesubstrate may include polyurethane or polyethylene foam, and thepolymerizable solvent composition may include methyl methacrylate. Atbox 704, the polymerizable solvent composition may be applied to thesubstrate. The polymerizable composition may react with the substrate toat least partially dissolve the substrate. The polymerizable compositionmay cure to form a textured surface at box 706. The textured surface maybe cleaned to remove residue of the substrate. The textured surface maybe used to form a mold at box 708.

[0061] A polymerizable composition may be applied to a textured positivemold to form a textured backing for a prosthesis. In an embodiment, thesame composition used to form the outer layer may be used. It has beenfound through experimentation that a mixture of about 3 parts LIM 6010Ato about 1 part LIM 6010B, or more specifically, about ratio of about 76grams of LIM 6010A to 26 grams of LIM 6010B, may have desirablecharacteristics for a textured back. The polymerizable composition maybe applied to the textured mold (e.g., by brushing, spraying, pouring,etc.). The polymerizable composition may be cured to form a texturedback. The textured back may be removed from the textured mold. Apolymerizable composition may be used to couple the textured back to theprosthesis. For example, a mixture in the ratio of about 12.5 grams ofLIM 6010A, about 12.5 grams of LIM 6010B, and about 3.5 grams ofcoloring agent may be used.

[0062] In an embodiment, a breast prosthesis may include multiplechambers as depicted in FIG. 8. For example, a breast prosthesis mayinclude an outer chamber 802, a back chamber 804, and one or moreintermediate chambers 806. The chambers may be separated by one or morepolymer layers 808. In an embodiment, the chambers may be castseparately, and then assembled. In an alternate embodiment, a firstchamber may be cast. The first chamber may then be placed in a mold usedto cast a second chamber during casting of the second chamber, and so onuntil a desired number of chambers are formed. The chambers may befilled with different materials to provide a realistic look and feel tothe prosthesis. For example, outer chamber 802 may be filled with a gelmaterial, back chamber 804 may be filled with a foam material, and anintermediate chamber 806 may be filled with air. Alternately, backchamber 804 may be filled with air and an intermediate chamber 806 maybe filled with foam material. Other materials which may be used mayinclude fluids of various densities and/or viscosities. Molds forforming the chambers may be formed as previously described. For example,a computer model of each chamber may be formed based on the computermodel of the prosthesis. The chambers may be sized such that eachchamber includes approximately one third of the prosthesis. However,depending on the patient's anatomy and the desired appearance of theprosthesis, each chamber may include significantly more or less of theprosthesis volume. For example, two chambers may include one quarter ofthe volume each, while the third chamber fills one half of the volume ofthe prosthesis. Additionally, more chambers may be used to form theprosthesis.

[0063] Typically, an external prosthetic device may be removably coupledto a patient. For example, a prosthesis may be removable coupled to apatient using adhesives. In an embodiment, a prosthetic may be formedwith a retaining harness integral with the prosthesis. In anotherembodiment, an osseointegrated retaining device may be surgicallyimplanted in a patient. A prosthesis may be coupled to theosseointegrated retaining device. In yet another embodiment, aprosthetic device may be coupled to a patient using one or more magnetsadhesively coupled to a patient. In still another embodiment, aprosthetic device may be coupled to a patient using one or moremale/female coupling devices, wherein at least one of the couplingdevices is adhesively coupled to a patient.

[0064]FIGS. 9a and 9 b depict an embodiment of a prosthetic device 902coupled to a patient 904 by one or more coupling devices 906. In variousembodiments, coupling devices 906 may include magnets and/or malecoupling devices. Additionally, one or more coupling receptors 910 maybe coupled to prosthetic device 902. In various embodiments, couplingreceptors 910 may include metallic inserts and/or female receptors.Interaction of coupling devices 906 and coupling receptors 910 may actto retain prosthetic device 902 in relation to patient 904 during use.Prosthetic device 902 may include a textured backing 908 as previouslydescribed.

[0065] In an embodiment, coupling receptor 910 may be placed in acompleted prosthesis 902 by preparing an opening 912 in the back of theprosthesis. For example, a surgical biopsy punch may be used to preparethe opening. Coupling receptor 910 may be placed in the preparedopening. Since the outer layer may be formed of a silicone material, ifthe coupling receptor includes a metallic insert, the metallic insertmay be selected to be substantially free of sharp edges, especially onthe portion facing the back. For example, the metallic insert may have acurved surface. If sharp edges are present, repeatedly placing andremoving the prosthesis may cause the metallic insert to cut through theouter layer. A polymerizable composition may be used to seal couplingreceptor 910 into opening 912. In an embodiment, the polymerizablecomposition used to form the outer layer may be used. For example, thepolymerizable composition may include a mixture in the ratio of about 10grams of LIM 6010A, about 10 grams of LIM 6010B, and about 5 grams ofcoloring agent. The polymerizable composition may be applied over theopening. In an embodiment, the polymerizable composition may flow pastthe edges of the coupling receptor to provide a secure seal. When thepolymerizable composition has cured, the prosthesis may be ready foruse.

[0066] An embodiment of a coupling device is depicted in FIG. 10. Asdepicted in FIG. 10, a coupling device 906 may include a magnet 1014disposed within a pouch 1000 for coupling a prosthetic device to apatient. Pouch 1000 may be formed to retain magnet 1014 and to adheremagnet 1014 to the patient. Pouch 1000 may include an adhesive-backedlayer 1002, one or more intermediate layers 1004, and a top layer 1006.Additionally, pouch 1000 may be provided with a protective layer 1008,to cover the adhesive and inhibit accidental adhesion of the pouchduring shipping, manufacture or handling of the pouch.

[0067] Top layer 1006 may provide added durability to the pouch, and actto retain magnet 1014 within the pouch. In an embodiment, top layer 1006may include a polymer film. For example, a suitable top layer mayinclude a polyurethane film. Alternately, a woven material may be usedfor top layer 1006. In an embodiment, top layer 1006 may include anopening through which magnet 1014 may be inserted into pouch 1000. In analternate embodiment, openings (1012 and 1010) may be providedprotective layer 1008 and adhesive-backed layer 1002 through whichmagnet 1014 may be inserted into pouch 1000.

[0068] Intermediate layer 1004 may include a spacer layer and/or anassembly layer. A spacer layer may provide added thickness to the pouchto ease inserting magnet 1014 into the pouch. A spacer layer may alsohelp to distribute pressure from using the pouch over the patient'sskin. An assembly layer may include an adhesive on each side, thuscoupling top layer 1006 to adhesive-backed layer 1002. In an embodiment,intermediate layer 1004 may include a film having an adhesive on bothsides. For example, 3M 9889 double coated tape, commercially availablefrom Minnesota Mining and Manufacturing of St. Paul, Minn., may be used.In an alternate embodiment, no assembly layer may be used. In such acase, top layer 1006 may be coupled directly to adhesive-backed layer1002. For example, adhesive may be applied to top layer 1006 oradhesive-backed layer 1002 to couple the layers. In another example, toplayer 1006 may include an adhesive on its backside (e.g., the side thatfaces adhesive-backed layer 1002) to couple top layer 1006 to theadhesive-backed layer. In yet another example, adhesive-backed layer1002 may include an adhesive layer on both sides. An advantage ofincluding an assembly layer may be that adhesives may not contact magnet1014 during use. Thus, magnet 1014 may be retained in pouch 1000 duringuse, and easily removed after use.

[0069] In an embodiment, adhesive-backed layer 1002 may include a foammedical tape. For example a polyethylene foam tape, such as 3M 9776tape, may be used. 3M 9776 tape is commercially available from MinnesotaMining and Manufacturing of St. Paul, Minn. In such an embodiment,adhesive-backed layer 1002 may couple magnet 1014 to the patient, aswell as provide some padding to the patient. Protective layer 1008 maybe selected to be compatible with the adhesive of adhesive-backed layer1002. Additionally, protective layer 1008 may be configured to makeremoval of protective layer 1008 relatively simple. For example,protective layer 1008 may include a pull-tab and/or a slit to makeremoving the protective layer easier.

[0070] In an embodiment, magnet 1014 may be composed of strong magnet,such as a permanent iron-boron-neodymium magnet. Such magnets arecommercially available from Electron Energy Corporation of Landisville,Pa. Other magnetic materials that may be used include, but are notlimited to, materials such as alnico, ferrite, barium ferrite, strontiumferrite, neodymium iron boron, samarium cobalt, iron oxide, or otherferromagnetic materials.

[0071] In an alternate embodiment, two layers of a polymer mayencapsulate magnet 1014. Magnet 1014 may or may not be removable frombetween the polymer layers. For example, a polymer foam tape may be usedto form a polymer layer. Bottom layer 1002 may include an adhesive forcoupling pouch 1000 to the patient. In yet another embodiment, couplingreceptor 910 may be magnetic. Thus, magnet 1014 may be implanted intothe prosthesis and a metallic insert may be coupled to the patient. Instill another embodiment, both coupling device 906 and coupling receptor910 may include magnets.

[0072] In an embodiment, coupling device 906 and coupling receptor 910may include complementary male and female shapes. For example, thecoupling device and coupling receptor may form a ball and socket typejoint. Other examples of suitable male and female couplers are describedin U.S. Pat. Nos. 5,855,606 and 5,700,288, which are incorporated hereinby reference as though fully set forth herein.

[0073] In an embodiment, a breast prosthesis 1100 may be formed with aretaining harness 1102 as depicted in FIGS. 11a and 11 b. Retainingharness 1102 may be formed of one or more polymer layers, such as thepolymer composition used to form the outer layer. Alternately, retainingharness 1102 may include a woven material. Retaining harness 1102 may beconfigured to be worn over the shoulders and behind the neck of thepatient. In an embodiment, retaining harness 1102 may also include oneor more straps 1104 that extend around the torso of the patient. If thepatient has an intact breast, prosthesis 1100 may include an opening1106 through which the intact breast may project. If a custom fitretaining harness 1102 is to be formed for a patient, the patient's backor entire upper torso may be scanned as previously described. A customfit retaining harness 1102 may also be formed by forming an impressionof the patient's anatomy, as is known in the art (e.g., with alginate,plaster, or other casting medium). Alternately, retaining harness 1102may include one or more size adjustments. An advantage of prosthesis1100 may be that it may be worn with or without a bra to provide anatural appearance to a patient.

[0074] In an embodiment, a breast prosthesis may be retained in relationto a patient by use of an osseointergrated retaining device 1200, asdepicted in FIGS. 12a and 12 b. Osseointegrated retaining device 1200may include a flange 1202, a percutaneous abutment connection 1204, afixation connector 1206, a fixture mount 1208, and a retaining connector1210. In an embodiment, flange 1202 and percutaneous abutment connection1204 may be formed of biocompatible materials, such as, but not limitedto: titanium, gold and/or surgical grade stainless steel. One or moreflanges 1202 may be surgically implanted in a patient's rib 1216 (e.g.,first, second, third, fourth or fifth costal). Percutaneous abutmentconnection 1204 may be coupled to flange 1202 using fixation connector1206. Fixation connector 1206 may be configured to interact withretaining connector 1210 to retain fixture mount 1208. For example,fixation connector 1206 may include a threaded opening for receivingretaining connector 1210. However, it is recognized that other types ofconnectors (e.g., bayonette connectors, interlocking connectors,ratcheting connectors, adhesives, etc.) may also be used. Fixture mount1208 may include an engaging member 1212 complementary to an engagingmember 1214 of prosthesis 1220. Additionally, fixture mount 1208 mayinclude reinforcing washer 1218. Reinforcing washer 1218 may be formedfrom a biocompatible material. During use, the patient may insertengaging member 1212 into engaging member 1214 of the prosthesis. Thus,prosthesis 1220 may be retained in position relative to the patient'sbody. Additionally, in some embodiment, the prosthesis may be free tomove over a range of motion dependent on the shape of complementaryengaging members.

[0075] While the present invention has been described with reference toparticular embodiments, it will be understood that the embodiments areillustrated and that the invention scope is not so limited. For example,embodiments of an osseointegrated retaining device may be used to retainother types of prostheses. Additionally, scanning computer model formingtechniques and/or solid model forming techniques as disclosed herein maybe used with other prosthesis forming processes. Any variations,modifications, additions and improvements to the embodiments describedare possible. These variations, modifications, additions andimprovements may fall within the scope of the invention as detailedwithin the following claims.

[0076] In this patent, certain U.S. patents, U.S. patent applications,and other materials (e.g., articles) have been incorporated byreference. The text of such U.S. patents, U.S. patent applications, andother materials is, however, only incorporated by reference to theextent that no conflict exists between such text and the otherstatements and drawings set forth herein. In the event of such conflict,then any such conflicting text in such incorporated by reference U.S.patents, U.S. patent applications, and other materials is specificallynot incorporated by reference in this patent.

What is claimed is:
 1. A breast prosthesis, comprising: an anteriorportion having a shape substantially resembling a human breast; and aposterior portion wherein the posterior portion has a shape configuredto conform to a portion of a chest wall of a patient using theprosthesis; and wherein the posterior portion comprises a texturedsurface.
 2. The prosthesis of claim 1, further comprising at least onelayer of a polymer on the anterior portion of the prosthesis forming anouter layer.
 3. The prosthesis of claim 1, further comprising at leastone layer of a polymer on the anterior portion of the prosthesis formingan outer layer, wherein the outer layer comprises a silicone polymer. 4.The prosthesis of claim 1, further comprising a polymer foam core withinthe anterior portion.
 5. The prosthesis of claim 1, wherein texturing ofthe textured surface is random.
 6. The prosthesis of claim 1, whereintexturing of the textured surface is nonrandom.
 7. The prosthesis ofclaim 1, wherein the textured surface comprises a silicone polymer. 8.The prosthesis of claim 1, further comprising at least one layer of apolymer on the anterior portion of the prosthesis forming an outerlayer, and a polymer foam core coupled to the outer layer.
 9. Theprosthesis of claim 1, further comprising at least one coupling devicefor coupling the prosthesis to the patient.
 10. The prosthesis of claim1, wherein at least a portion of the posterior portion is configured tonot touch the patient during use.
 11. A method of forming a breastprosthesis, comprising: providing a breast prosthesis mold; forming anouter layer on at least a portion of the interior of the mold, whereinthe outer layer comprises at least one layer of a polymer; filling atleast a portion of the mold with a polymerizable foaming composition;curing the polymerizable foaming composition; and coupling the outerlayer to the cured foaming composition.
 12. The method of claim 11,wherein forming the outer layer comprises applying a polymerizablecomposition on at least a portion of the interior of the mold, andcuring the polymerizable composition to form a polymer layer.
 13. Themethod of claim 11, wherein forming the outer layer comprises repeatedlyapplying polymerizable composition on at least a portion of the interiorof the mold and curing the polymerizable composition to form a pluralityof polymer layers on the interior of the mold.
 14. The method of claim11, further comprising applying at least one coloring agent to the outerlayer.
 15. The method of claim 11, wherein at least one layer of apolymer comprises a silicone polymer.
 16. The method of claim 11,further comprising applying at least one coloring agent to the outerlayer, wherein at least one coloring agent comprises a siliconedispersion.
 17. The method of claim 11, further comprising applying atleast one coloring agent to the outer layer, wherein at least onecoloring agent is selected to substantially match skin color of apatient.
 18. The method of claim 11, wherein forming the outer layercomprises forming a first polymer layer on at least a portion of theinterior of the mold, applying a coloring agent to the first polymerlayer, and forming at least one additional polymer layer over theapplied coloring agent.
 19. The method of claim 11, wherein thepolymerizable foaming composition comprises a mixture of two or moresubstances, wherein upon mixing, the two or more substances react tocause foaming of the mixture and to initiate polymerization of themixture.
 20. The method of claim 11, further comprising assembling themold before completing curing of the polymerizable foaming composition.21. The method of claim 11, further comprising inhibiting expansion ofthe polymerizable foaming composition beyond the mold.
 22. The method ofclaim 11, further comprising removing the polymerizable foamingcomposition from the mold after curing.
 23. The method of claim 11,further comprising removing the polymerizable foaming composition fromthe mold after curing, and modifying the shape of the cured foamingcomposition.
 24. The method of claim 11, further comprising applying atleast one coloring agent to the cured foaming composition.
 25. Themethod of claim 11, wherein coupling the outer layer to the curedfoaming composition comprises removing the cured foaming compositionfrom the mold, applying a polymerizable composition on at least aportion of the interior of the mold, placing the cured foamingcomposition into substantially even contact with the polymerizablecomposition and curing the polymerizable composition to adhere the curedfoaming composition to the outer layer.
 26. The method of claim 11,further comprising forming at least one polymer layer on an exposedportion of the cured foaming composition.
 27. The method of claim 26,wherein forming at least one polymer layer on an exposed portion of thecured foaming composition comprises applying at least one layer of apolymerizable composition to an exposed portion of the cured foamingcomposition and curing the polymerizable composition.
 28. The method ofclaim 26, wherein forming at least one polymer layer on an exposedportion of the cured foaming composition comprises providing a texturedpolymer layer, wherein the textured polymer layer comprises at least onetextured surface, and coupling the textured polymer layer to an exposedportion of the cured foaming composition.
 29. The method of claim 11,wherein the outer layer comprises one or more layers of a siliconepolymer.
 30. The method of claim 11, wherein the polymerizable foamingcomposition comprises a reaction product of a polyol and an isocyanate.31. The method of claim 11, wherein the polymerizable foamingcomposition comprises a polyurethane foam.
 32. A method of forming amodel of a breast prosthesis, comprising: providing a scanning systemcomprising at least one imaging device, and at least one alignmentmarker; arranging at least one alignment marker with respect to apatient and within the field of view of the imaging device; determininga first set of data elements using the scanning system, wherein thefirst set of data elements is based on the shape of a patient's breast;determining a computer model of a breast prosthesis based on the firstset of data elements; and using at least one alignment marker todetermine alignment of the computer model.
 33. The method of claim 32,further comprising storing the computer model on a memory medium. 34.The method of claim 32, wherein the scanning system further comprises anorientation marker.
 35. The method of claim 32, wherein the scanningsystem further comprises an orientation marker, and wherein the methodfurther comprises arranging the orientation marker with respect to apatient and within the field of view of the imaging device, anddetermining orientation of the computer model of the breast using theorientation marker.
 36. The method of claim 32, wherein the first set ofdata elements is based on the shape of the patient's breast while thebreast is at least partially covered by a garment.
 37. The method ofclaim 32, wherein the imaging device comprises at least one light sourceand at least one light detector, and wherein determining the first setof data elements comprises sweeping light from at least one light sourceover the patient's breast, and detecting reflected light with at leastone light detector.
 38. The method of claim 37, wherein the light sourcecomprises a laser light source.
 39. The method of claim 32, wherein theimaging device comprises at least electromagnetic radiation source andat least one electromagnetic radiation detector, and wherein determiningthe first set of data elements comprises exposing the patient toelectromagnetic radiation from at least one electromagnetic radiationsource, and detecting reflected electromagnetic radiation with at leastone electromagnetic radiation detector.
 40. The method of claim 39,wherein at least one electromagnetic radiation source comprises amillimeter wave source.
 41. The method of claim 32, wherein determininga computer model of a breast prosthesis based on the first set of dataelements comprises modifying the first set of data elements to removedate elements corresponding to a garment at least partially covering thepatient's breast.
 42. The method of claim 32, further comprisingdetermining a second set of data elements, wherein the second set ofdata elements represents a mirror image of the computer model of abreast prosthesis.
 43. The method of claim 32, further comprisingscanning a patient's chest in an area where a breast prosthesis is to beused, and forming a computer model of at least a portion of thepatient's chest.
 44. The method of claim 43, further comprisingcombining the computer model of the breast prosthesis with the computermodel of at least a portion of the patient's chest, wherein the computermodel of the breast prosthesis forms a first side of the combined model,and the computer model of at least a portion of the patient's chestforms a second side of the combined model.
 45. The method of claim 32,wherein at least one alignment marker comprises a self-adhesive member.46. The method of claim 32, wherein determining the first set of dataelements comprises sweeping light from at least one light source overthe a portion of the patient's anatomy comprising the at least thepatient's breast, and detecting reflected light, wherein at least onealignment marker reflects light more strongly than the patient's skin.47. The method of claim 32, wherein determining the first set of dataelements comprises sweeping light from at least one light source overthe a portion of the patient's anatomy comprising the at least thepatient's breast, and detecting reflected light, wherein at least onealignment marker reflects light less strongly than the patient's skin.48. The method of claim 32, wherein the scanning system furthercomprises at least one orientation marker, wherein at least oneorientation marker comprises an elongated member.
 49. The method ofclaim 32, wherein the scanning system further comprises at least oneorientation marker, and wherein the method further comprises arrangingat least one orientation marker with respect to the patient.
 50. Themethod of claim 49, further comprising determining orientation in thecomputer model, wherein determining orientation in the computer modelcomprises determining the shape of the orientation marker in thecomputer model.
 51. The method of claim 32, further comprising sending acontrol signal to a rapid prototyping system, wherein the rapidprototyping system is configured to generate a solid model of the breastprosthesis based on the computer model of the breast prosthesis.
 52. Themethod of claim 51, wherein the rapid prototyping system comprises acomputer numerical controlled milling system.
 53. The method of claim51, wherein the rapid prototyping system comprises a laser sinteringsystem.
 54. The method of claim 51, wherein the rapid prototyping systemcomprises a stereo lithography system.
 55. A method of forming a modelof a breast prosthesis, comprising: providing a scanning systemcomprising at least one imaging device, and at least one alignmentmarker; arranging at least one alignment marker with respect to apatient and within the field of view of the imaging device; determininga first set of data elements using the scanning system, wherein thefirst set of data elements is based on the shape of garment; determininga computer model of a breast prosthesis based on the first set of dataelements; and using at least one alignment marker to determine alignmentof the computer model.
 56. The method of claim 55, wherein the garmentcomprises a bra cup.
 57. The method of claim 55, wherein the garmentcomprises a bra cup filled with a breast form.
 58. The method of claim55, further comprising shaping the garment to a desired shape beforedetermining the first set of data elements.
 59. The method of claim 55,further comprising storing the computer model on a memory medium. 60.The method of claim 55, wherein the scanning system further comprises anorientation marker.
 61. The method of claim 55, wherein the scanningsystem further comprises an orientation marker, and wherein the methodfurther comprises arranging the orientation marker with respect to apatient and within the field of view of the imaging device, anddetermining orientation of the computer model of the breast using theorientation marker.
 62. The method of claim 55, wherein the imagingdevice comprises at least one light source and at least one lightdetector, and wherein determining the first set of data elementscomprises sweeping light from at least one light source over thegarment, and detecting reflected light with at least one light detector.63. The method of claim 62, wherein the light source comprises a laserlight source.
 64. The method of claim 55, wherein the imaging devicecomprises at least electromagnetic radiation source and at least oneelectromagnetic radiation detector, and wherein determining the firstset of data elements comprises exposing the garment to electromagneticradiation from at least one electromagnetic radiation source, anddetecting reflected electromagnetic radiation with at least oneelectromagnetic radiation detector.
 65. The method of claim 64, whereinat least one electromagnetic radiation source comprises a millimeterwave source.
 66. The method of claim 55, further comprising determininga second set of data elements, wherein the second set of data elementsrepresents a mirror image of the computer model of a breast prosthesis.67. The method of claim 55, further comprising scanning a patient'schest in an area where a breast prosthesis is to be used, and forming acomputer model of at least a portion of the patient's chest.
 68. Themethod of claim 67, further comprising combining the computer model ofthe breast prosthesis with the computer model of at least a portion ofthe patient's chest, wherein the computer model of the breast prosthesisforms a first side of the combined model, and the computer model of atleast a portion of the patient's chest forms a second side of thecombined model.
 69. The method of claim 55, wherein at least onealignment marker comprises a self-adhesive member.
 70. The method ofclaim 55, wherein the scanning system further comprises at least oneorientation marker, wherein at least one orientation marker comprises anelongated member.
 71. The method of claim 55, wherein the scanningsystem further comprises at least one orientation marker, and whereinthe method further comprises arranging at least one orientation markerwith respect to the patient.
 72. The method of claim 71, furthercomprising determining orientation in the computer model, whereindetermining orientation in the computer model comprises determining theshape of the orientation marker in the computer model.
 73. The method ofclaim 55, further comprising sending a control signal to a rapidprototyping system, wherein the rapid prototyping system is configuredto generate a solid model of the breast prosthesis based on the computermodel of the breast prosthesis.
 74. The method of claim 73, wherein therapid prototyping system comprises a computer numerical controlledmilling system.
 75. The method of claim 73, wherein the rapidprototyping system comprises a laser sintering system.
 76. The method ofclaim 73, wherein the rapid prototyping system comprises a stereolithography system.
 77. A system for forming a computerized model of abreast prosthesis: an imaging device; and a computer system incommunication with the imaging device, wherein the computer system isconfigured to determine a computerized model of a breast based oninformation from the imaging device, wherein the computer is configuredto determine a computerized model of a patient's chest wall based oninformation from the imaging device, and wherein the computer system isconfigured to combine the computerized model of the breast and thecomputerized model of the patient's chest wall to form a computerizedmodel of a breast prosthesis.
 78. The system of claim 77, wherein theimaging device is configured to scan a patient using laser light. 79.The system of claim 77, wherein the imaging device is configured to scana patient using electromagnetic radiation.
 80. The system of claim 77,wherein the computer system is further configured to determine a mirrorimage of the computerized model of the breast.
 81. The system of claim77, wherein the imaging device and the computer system are incommunication via a network.
 82. The system of claim 77, furthercomprising a memory medium coupled to the imaging device, wherein theimaging device is configured to scan a patient and save information fromthe scan to the memory medium.
 83. The system of claim 82, wherein thecomputer system is configured to access information on the memory mediumto determine the computerized model of the patient's breast.
 84. Thesystem of claim 82, wherein the computer system is configured to accessinformation on the memory medium to determine the computerized model ofthe patient's chest wall.
 85. A carrier medium comprising programinstructions, wherein the program instructions are computer-executableto implement a method comprising: receiving a first set of data elementsdetermined by scanning a patient over an area including at least onebreast wherein the first set of data elements corresponds to a firstsurface; determining a second set of data elements, wherein the secondset of data elements corresponds to a second surface, and wherein thesecond surface is a mirror image of the first surface; and determining acomputerized model of a breast prosthesis based on the second set ofdata elements.
 86. The carrier medium of claim 85, wherein the methodfurther comprises generating a graphical display of the computerizedmodel of the breast prosthesis.
 87. The carrier medium of claim 85,wherein the method further comprises saving data elements correspondingto the computerized model of the breast prosthesis in a memory.
 88. Thecarrier medium of claim 85, wherein the method further comprises sendinga signal to a rapid prototyping system based on the computerized modelof the breast prosthesis, wherein the signal is configured to provideinstructions to the rapid prototyping system for generating a model ofthe breast prosthesis.
 89. The carrier medium of claim 85, wherein themethod further comprises modifying the first set of data objects tosmooth the first surface.
 90. The carrier medium of claim 85, whereinthe method further comprises modifying the second set of data objects tosmooth the second surface.
 91. The carrier medium of claim 85, whereinthe method further comprises modifying the first set of data objects byadding data elements approximately corresponding to missing dataelements.
 92. The carrier medium of claim 85, wherein the method furthercomprises modifying the second set of data objects by adding dataelements approximately corresponding to missing data elements.
 93. Thecarrier medium of claim 85, wherein the method further comprisesmodifying the first set of data elements to include data elementscorresponding to at least one anatomical feature not represented in thereceived first set of data elements.
 94. The carrier medium of claim 85,wherein the method further comprises modifying the second set of dataelements to include data elements corresponding to at least oneanatomical feature not represented in the first set of data elements.95. The carrier medium of claim 85, wherein the method further comprisesmodifying the first set of data elements to remove data elementscorresponding to at least one anatomical feature represented in thereceived first set of data elements.
 96. The carrier medium of claim 85,wherein the method further comprises modifying the second set of dataelements to remove data elements corresponding to at least oneanatomical feature represented in the first set of data elements. 97.The carrier medium of claim 85, wherein determining a computerized modelof the breast prosthesis based on the second set of data elementscomprises receiving a third set of data elements determined by scanninga patient over an area including at least a location where the breastprosthesis will be used, wherein the third set of data elementscorrespond to a third surface, and combining the second set of dataelements and the third set of data elements to form the computerizedmodel of the breast prosthesis.
 98. The carrier medium of claim 97,wherein the method further comprises modifying the third set of dataobjects to smooth the third surface.
 99. The carrier medium of claim 97,wherein the method further comprises modifying the third set of dataobjects by determine data elements approximately corresponding tomissing data elements.
 100. The carrier medium of claim 97, wherein themethod further comprises modifying the third set of data elements toinclude data elements not represented in the received third set of dataelements.
 101. The carrier medium of claim 97, wherein the methodfurther comprises modifying the third set of data elements to removedata elements in the received third set of data elements.
 102. A methodof coupling a prosthesis to a patient comprising: providing a prosthesiscomprising at least one metallic insert; adhering at least one magnet tothe patient, wherein at least one magnet adhered to the patient alignswith at least one metallic insert of the prosthesis during use of theprosthesis; and coupling the prosthesis to the patient such that atleast one magnet and at least one metallic insert are alignedsufficiently to retain the prosthesis.
 103. The method of claim 102,wherein prosthesis comprises a breast prosthesis.
 104. The method ofclaim 102, wherein the magnet comprises an iron-boron-neodymium magnet.105. The method of claim 102, wherein the metallic insert comprises arounded surface.
 106. The method of claim 102, wherein adhering at leastone magnet to the patient comprises placing at least one magnet in apouch, and adhering the pouch to the patient.
 107. The method of claim106, wherein the pouch comprises an adhesive layer coupled to a toplayer, wherein the top layer is configured to retain at least onemagnet, and wherein the adhesive layer is configured to couple the pouchto the patient.
 108. The method of claim 106, wherein the pouchcomprises a top foam layer coupled to a bottom foam layer, and anopening between the top foam layer and the bottom foam layer configuredto retain at least one magnet, and wherein the bottom foam layer isconfigured to couple the pouch to the patient.
 109. The method of claim106, wherein adhering at least one magnet to the patient comprisespeeling a protective backing off of an adhesive layer of the pouch, andplacing the adhesive layer in contact with the patient.
 110. A method ofcoupling a prosthesis to a patient comprising: providing a prosthesiscomprising at least one female coupling receptor; adhering at least onemale coupling device to the patient, wherein at least one male couplingdevice adhered to the patient aligns with at least one female couplingreceptor of the prosthesis during use of the prosthesis; and couplingthe prosthesis to the patient such that at least one male couplingdevice and at least one female coupling receptor are inter-engaged. 111.A device for retaining a prosthesis comprising: a top layer, wherein thetop layer is configured to retain a magnet; and a bottom layer coupledto the top layer, wherein the bottom layer comprises an adhesive, andwherein the bottom layer is configured to be coupled to a patient duringuse.
 112. The device of claim 111, wherein the top layer comprises anopen configured to receive the magnet.
 113. The device of claim 111,wherein the top layer comprises a polymer film.
 114. The device of claim111, wherein the top layer comprises a woven material.
 115. The deviceof claim 111, wherein the bottom layer comprises a polymer foam. 116.The device of claim 111, further comprising a protective layer coupledto the bottom layer, wherein the protective layer is configured toinhibit unintended adhesion of the adhesive.
 117. The device of claim111, wherein the protective layer comprises a pull tab.
 118. The deviceof claim 111, wherein the protective layer comprises a
 119. The deviceof claim 111, further comprising at least one intermediate layer betweenthe top layer and the bottom layer.
 120. The device of claim 119,wherein at least one intermediate layer comprises an opening configuredto receive the magnet.
 121. The device of claim 111, wherein at leastone intermediate layer comprises an assembly layer.
 122. A prosthesis,comprising: a body; at least one metallic insert coupled to the body; atleast one magnet configured to be adhesively coupled to a patient;wherein, during use, at least one magnet interacts with at least onemetallic insert to couple the prosthesis to the patient.
 123. Theprosthesis of claim 122, wherein the body comprises a breast prosthesis.124. The prosthesis of claim 122, wherein at least one metallic insertcoupled to the body is at least partially covered by a polymer layer.125. The prosthesis of claim 122, wherein at least one metallic insertcomprises a rounded surface.
 126. The prosthesis of claim 122, whereinat least one magnet comprises an iron-boron-neodymium magnet.
 127. Theprosthesis of claim 122, further comprising a pouch comprising anopening, wherein the opening of the pouch is configured to receive atleast one magnet, and wherein the pouch is configured to be adhesivelycoupled to the patient.
 128. The prosthesis of claim 127, wherein thepouch further comprises at least one layer of a foam material.
 129. Theprosthesis of claim 122, wherein the body comprises at least one layerof a polymer on a portion of the prosthesis forming an outer layer. 130.The prosthesis of claim 122, wherein the body comprises a siliconepolymer.
 131. The prosthesis of claim 122, wherein the body comprises apolymer foam core.
 132. The prosthesis of claim 122, wherein the bodycomprises a textured back surface.
 133. A prosthesis, comprising: abody; at least one female coupling receptor coupled to the body; atleast one male coupling device configured to be adhesively coupled to apatient; wherein, during use, at least one male coupling deviceinteracts with at least one female coupling receptor to couple theprosthesis to the patient.
 134. A breast prosthesis, comprising: a body,wherein the body comprises a plurality of chambers, wherein at least onechamber comprises a gel, and wherein at least one chamber comprises afoam material.
 135. The breast prosthesis of claim 134, wherein the bodyfurther comprises at least one layer of a polymer separating at leasttwo chambers.
 136. The breast prosthesis of claim 134, wherein the bodyfurther comprises at least one chamber comprising air.
 137. The breastprosthesis of claim 134, wherein the body comprises at least one layerof a polymer on a portion of the prosthesis forming an outer layer. 138.The breast prosthesis of claim 134, wherein the body comprises asilicone polymer.
 139. The breast prosthesis of claim 134, wherein thebody comprises a textured back surface.
 140. The breast prosthesis ofclaim 134, further comprising at least one device configured to couplethe body to a patient, during use.
 141. A device for retainingprosthesis comprising: a flange; a percutaneous abutment; a fixationconnector; a fixture mount; and a retaining connector.
 142. A breastprosthesis comprising: a body; and a retaining harness integral with thebody, wherein the retaining harness is configured to extend behind apatient's neck.
 143. The prosthesis of claim 142, wherein the retainingharness further comprises at least one strap configured to extend behinda patient's back.
 144. The prosthesis of claim 142, wherein theretaining harness comprises an opening configured to allow an intactbreast to project through the opening.
 145. The prosthesis of claim 142,wherein the body comprises a plurality of chambers, wherein at least onechamber comprises a gel, and wherein at least one chamber comprises afoam material.
 146. The prosthesis of claim 145, wherein the bodyfurther comprises at least one layer of a polymer separating at leasttwo chambers.
 147. The prosthesis of claim 145, wherein the body furthercomprises at least one chamber comprising air.
 148. The prosthesis ofclaim 142, wherein the body comprises at least one layer of a polymer ona portion of the prosthesis forming an outer layer.
 149. The prosthesisof claim 142, wherein the body comprises a silicone polymer.
 150. Theprosthesis of claim 142, wherein the body comprises a textured backsurface.
 151. A method of forming a textured mold, comprising: providinga substrate: applying a polymerizable solvent composition to at least aportion of the substrate; curing the polymerizable solvent compositionto form a textured surface on the cured polymerizable solventcomposition; and forming a mold of the textured surface of the curedpolymerizable solvent composition.
 152. The method of claim 151, whereinthe polymerizable solvent composition comprises methyl methacrylate.153. The method of claim 151, wherein the substrate comprises a polymerfoam that is at least partially soluble in the polymerizable solventcomposition.
 154. The method of claim 151, wherein the substratecomprises polyurethane.
 155. The method of claim 151, wherein thesubstrate comprises polyethylene.